RecruitingPhase 1Phase 2NCT06613477

PK/PD of Digoxin in Infants With SVHD

Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease


Sponsor

Duke University

Enrollment

20 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function. The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic"). The investigators will also collect information from medical records. Being part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.


Eligibility

Min Age: 30 DaysMax Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease for people with infant conditions, infant, newborn, diseases, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease

Table 3: Digoxin dosing regimen based on optimized Cmin,ss Dose to be given twice daily (mcg/kg/dose) PNA\<30 days 30 days \< PNA \< 180 days eGFR≤40 1.4 1.4 40\<eGFR≤60 1.6 1.6 eGFR\>60 1.9 2.8


Locations(2)

Duke University Medical Center

Durham, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06613477


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